Clearance Summary
MODIFICATION TO ENSITE SYSTEM, MODEL EE3000 received FDA 510(k) clearance under submission number K060954, sponsored by St. Jude Medical, Inc.-Endocardial Solutions. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-04-21.
- Submission: K060954
- Applicant / Sponsor: St. Jude Medical, Inc.-Endocardial Solutions
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2006-04-21
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.